Treatment of Peritonitis in Automated Peritoneal Dialysis

NCT04077996 | Completed Results DMC

• 1 other identifier: 01APDPERITONITIS
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 3

Brief Summary

The main infectious complication of peritoneal dialysis (PD) is bacterial peritonitis, which increases morbidity, mortality and conversion to hemodialysis. In Mexico, 485 patients per million people undergo PD. The Mexican Institute of Social Security (IMSS) reported 55,101 patients with kidney failure, 59% on PD. Automated PD (APD) has contributed by reducing peritonitis. The treatment of peritonitis in APD is carried out by changing to continuous ambulatory peritoneal dialysis (CAPD) or by adding a CAPD/day replacement, increasing costs and delaying treatment. OBJECTIVE: To compare the efficacy of peritonitis antibiotic treatment applied in a DPA bag versus applied in a CAPD/day replacement plus APD in IMSS beneficiaries. MATERIAL AND METHODS: A non-inferiority, multicenter clinical trial was carried out with patients\> 18 years of age in APD with peritonitis. Group 1 (g1) receives antibiotics in DPA bags, group 2 (g2) receives antibiotics in a CAPD / day exchange plus APD. The antibiotics applied were ceftazidime 1500 mg / day 14 days and vancomycin 20 mg / kg every 3 days, 5 doses adjusted according to culture, followed by cytology every 48 hours until clinical resolution. Considering resolved peritonitis when symptoms disappeared and white blood cells \<100 cells / mm3 were obtained in cytology. The Research and Ethics Committee approved the study. Relative risk (RR), relative risk reduction (RRR) were calculated. The Chi squared test, Student's t test, non-inferiority analysis was calculated considering p \<0.05 significant, SPSS 24 and Epi Info were used.

Conditions

Secondary Peritonitis

Keywords

PERITONITIS; AUTOMATED PERITONEAL DIALYSIS; TREATMENT OF PERITONITIS

Outcome Measures

Primary Outcomes (1)

• Peritonitis Resolved

  We consider the problem resolved when symptoms (nausea, vomiting, abdominal pain, fever, turbid fluid) have disappeared and negative cytology has been obtained (leukocytes \<100 cells/mm3)

  14 to 21 days

Secondary Outcomes (1)

• Death of Patient

  21 days

Study Arms (2)

Peritonitis treatment with one exchange in CAPD

ACTIVE COMPARATOR

This group will receive peritonitis treatment with one exchange on Continuous Ambulatory Peritoneal Dialysis per day. The initial antibiotic scheme will be with ceftazidime (1500mg/day) and vancomycin (20mg/kg every 3 days) according to current management guidelines; adjusting the management according to the result of the culture, completing the antibiotic scheme for 14 to 21 days.

Device: Peritonitis treatment with one exchange in CAPD

Peritonitis treatment placed in APD

EXPERIMENTAL

This group will receive peritonitis treatment placed in Automated Peritoneal Dialysis. The initial antibiotic scheme will be with ceftazidime (1500mg/day) and vancomycin (20mg/kg every 3 days); adjusting the management according to the result of the culture, completing the antibiotic scheme for 14 to 21 days.

Device: Peritonitis treatment placed in APD

Interventions

Peritonitis treatment placed in APD DEVICE

Antibiotic treatment of peritontiis placed in bags of Automated peritoneal dialysis.

Peritonitis treatment placed in APD

Peritonitis treatment with one exchange in CAPD DEVICE

Antibiotic treatment of peritontiis placed in one bag of Continuos ambulatory peritoneal dialysis per 6 hours each day.

Peritonitis treatment with one exchange in CAPD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 18 years in Automated Peritoneal Dialysis.
• Patients in the Hospital General 1, 10 and sub-zone 4 of Colima.
• Patients with diagnosis of peritonitis (abdominal pain, fever, vomiting, nausea, turbid fluid, cytologic with leukocytes \>100 cells/mm3, polymorphonuclear \>50%).
• Functional catheter.
• Signed informed consent of acceptance to participate in the study.

You may not qualify if:

• Patients allergic to vancomicyn.
• Patients allergic to ceftazidime.
• Patients with Intestinal perforation.
• Patients with abdominal cavity classified as unfit to PD.

Sponsors & Collaborators

• Universidad de Colima: lead
• Instituto Mexicano del Seguro Social: collaborator

Study Sites (3)

Hgz 10 Instituto Mexicano Del Seguro Social

Manzanillo, Colima, 28100, Mexico

Location

Hgsz 4 Instituto Mexicano Del Seguro Social

Tecomán, Colima, 28100, Mexico

Location

Hgz 1 Instituto Mexicano Del Seguro Social

Colima, 28979, Mexico

Location

Related Publications (12)

• Li PK, Kwong VW. Current Challenges and Opportunities in PD. Semin Nephrol. 2017 Jan;37(1):2-9. doi: 10.1016/j.semnephrol.2016.10.002.

  PMID: 28153192 BACKGROUND

• Li PK, Szeto CC, Piraino B, de Arteaga J, Fan S, Figueiredo AE, Fish DN, Goffin E, Kim YL, Salzer W, Struijk DG, Teitelbaum I, Johnson DW. ISPD Peritonitis Recommendations: 2016 Update on Prevention and Treatment. Perit Dial Int. 2016 Sep 10;36(5):481-508. doi: 10.3747/pdi.2016.00078. Epub 2016 Jun 9. No abstract available.

  PMID: 27282851 BACKGROUND

• Ruger W, van Ittersum FJ, Comazzetto LF, Hoeks SE, ter Wee PM. Similar peritonitis outcome in CAPD and APD patients with dialysis modality continuation during peritonitis. Perit Dial Int. 2011 Jan-Feb;31(1):39-47. doi: 10.3747/pdi.2009.00235. Epub 2010 Jun 17.

  PMID: 20558813 BACKGROUND

• Fielding RE, Clemenger M, Goldberg L, Brown EA. Treatment and outcome of peritonitis in automated peritoneal dialysis, using a once-daily cefazolin-based regimen. Perit Dial Int. 2002 May-Jun;22(3):345-9.

  PMID: 12227392 BACKGROUND

• Lan PG, Johnson DW, McDonald SP, Boudville N, Borlace M, Badve SV, Sud K, Clayton PA. The association between peritoneal dialysis modality and peritonitis. Clin J Am Soc Nephrol. 2014 Jun 6;9(6):1091-7. doi: 10.2215/CJN.09730913. Epub 2014 Mar 13.

  PMID: 24626434 BACKGROUND

• de Moraes TP, Olandoski M, Caramori JC, Martin LC, Fernandes N, Divino-Filho JC, Pecoits-Filho R, Barretti P. Novel predictors of peritonitis-related outcomes in the BRAZPD cohort. Perit Dial Int. 2014 Mar-Apr;34(2):179-87. doi: 10.3747/pdi.2012.00333. Epub 2014 Jan 2.

  PMID: 24385333 BACKGROUND

• El-Reshaid W, Al-Disawy H, Nassef H, Alhelaly U. Comparison of peritonitis rates and patient survival in automated and continuous ambulatory peritoneal dialysis: a 10-year single center experience. Ren Fail. 2016 Sep;38(8):1187-92. doi: 10.1080/0886022X.2016.1209025. Epub 2016 Jul 19.

  PMID: 27435043 BACKGROUND

• Sanchez AR, Madonia C, Rascon-Pacheco RA. Improved patient/technique survival and peritonitis rates in patients treated with automated peritoneal dialysis when compared to continuous ambulatory peritoneal dialysis in a Mexican PD center. Kidney Int Suppl. 2008 Apr;(108):S76-80. doi: 10.1038/sj.ki.5002606.

  PMID: 18379553 BACKGROUND

• Peerapornratana S, Chariyavilaskul P, Kanjanabuch T, Praditpornsilpa K, Eiam-Ong S, Katavetin P. Short-Dwell Cycling Intraperitoneal Cefazolin Plus Ceftazidime in Peritoneal Dialysis Patients. Perit Dial Int. 2017 Mar-Apr;37(2):218-224. doi: 10.3747/pdi.2015.00300. Epub 2016 Oct 13.

  PMID: 27738089 BACKGROUND

• Deslandes G, Gregoire M, Bouquie R, Le Marec A, Allard S, Dailly E, Pineau A, Allain-Launay E, Jolliet P, Roussey G, Navas D. Stability and Compatibility of Antibiotics in Peritoneal Dialysis Solutions Applied to Automated Peritoneal Dialysis in The Pediatric Population. Perit Dial Int. 2016 11-12;36(6):676-679. doi: 10.3747/pdi.2015.00018. Epub 2016 May 4.

  PMID: 27147292 BACKGROUND

• Odudu A, Wilkie M. Controversies in the management of infective complications of peritoneal dialysis. Nephron Clin Pract. 2011;118(3):c301-8. doi: 10.1159/000322227. Epub 2011 Jan 14.

  PMID: 21242698 BACKGROUND

• Venegas-Ramirez J, Trujillo-Hernandez B, Castillon-Flores CC, Landin-Herrera FJ, Herrera-Oliva E, Calvo-Soto P, Tapia-Vargas R, Figueroa-Gutierrez A, Rios-Bracamontes EF, Espinoza-Mejia KE, Jimenez-Vieyra IA, Bermudez-Aceves LA, Avila-Flores BJ, Murillo-Zamora E. Simplifying Antibiotic Management of Peritonitis in APD: Evidence from a Non-Inferiority Randomized Trial. Antibiotics (Basel). 2025 Jul 24;14(8):747. doi: 10.3390/antibiotics14080747.

  PMID: 40867942 DERIVED

MeSH Terms

Conditions

Peritonitis

Interventions

Peritoneal Dialysis, Continuous Ambulatory

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Peritoneal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ambulatory Care; Patient Care; Therapeutics; Peritoneal Dialysis; Renal Dialysis; Renal Replacement Therapy; Sorption Detoxification; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Jesus Venegas-Ramírez
• Organization: Instituto Mexicano del Seguro Social

nefrojesusvr@gmail.com, jesus.venegas@imss.gob.mx

3143058373

Study Officials

• Benjamin Trujillo, DS

  Universidad de Colima

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: the outcomes assessor will mask to do statistical analisis
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master Degree

Model Details: Patients will be randomly through table of random numbers, and divided to form two treatment groups with 32 patients per group. One of which will be a APD and the other a CAPD + APD. The initial antibiotic scheme will be applied to both groups continuously based on: ceftazidime (1500-2000mg/day) and vancomycin (20mg/kg every 3 days) according to current management guidelines;

Study Record Dates

• First Submitted: September 1, 2019
• First Posted: September 4, 2019
• Study Start: July 1, 2019
• Primary Completion: July 30, 2021
• Study Completion: August 30, 2022
• Last Updated: March 26, 2025
• Results First Posted: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (3)